Phase 3
N=1,791
Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00032487 ↗Enrolled (actual)
1,791
Serious AEs
19.0%
Results posted
Feb 2014
Primary outcome: Primary: Primary Major Macrovascular Events — 264; 235 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Insulin (Drug); Glimepiride (Drug); Rosiglitazone (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Major Macrovascular Events |
264; 235 | <0.05 sig |
| SECONDARY Secondary Endpoint |
283; 312 | — |
Summary
This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 DM who are no longer responsive to maximum dose of one or more oral agents.
Exclusion Criteria
- Angina pectoris, Canadian Class I-II,
- congestive heart failure, Class III-IV,
- stroke, incapacitating or in last 6 months,
- Myocardial infarction (MI) or invasive cardiovascular procedure within the past six months,
- ongoing diabetic gangrene,
- BMI > 40,
- hemoglobinopathy that interferes with A1c monitoring,
- serum creatinine > 1.6 mg/dL,
- fasting C-peptide 3 times normal or serum bilirubin > 1.9 mg/dL,
- malignancy or noncardiac life-threatening diseases making life expectancy < 5 years,
- autonomic neuropathy,
- symptomatic pancreatic insufficiency (endocrine or exocrine),
- recurrent seizures within the past year,
- hypopituitarism,
- pregnancy, lactation, or planning a pregnancy,
- active psychosis or substance abuse,
- lack of access to a person who can assist or be called in an emergency,
- underlying conditions that in the site PI's judgment may prevent adherence to protocol,
- current participation in another clinical trial
Data sourced from ClinicalTrials.gov (NCT00032487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.